Quality Assurance
Leading Our Quality Assurance
Service
Christine
Twine, Vice President, Quality Assurance
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In addition to supporting Constella’s in-house clinical work, we provide expert services to pharmaceutical, biotechnology, and device companies, including assessments of internal client procedures and reviews of investigative site-specific documentation. Whether you are looking to develop and implement quality systems from scratch, or need to standardize and review the compliance of your existing systems, or your contractors’ systems, Constella QA’s experienced team of auditors can help you. We offer a comprehensive set of services such as regulatory audits, GxP system audits, GCP project audits, GxP training, laboratory services, manufacturing services, EU Directive on clinical trials consultancy, SOP writing, and online services.
GxP System Audits |
In a detailed assessment of your quality systems and processes, we will highlight problem areas and recommend improvements, so you can be sure you have everything covered right from the start. We can also conduct similar activities on your behalf for third-party contractors. The audits will be tailored to your particular GxP needs with an understanding of the spectrum of requirements across all stages of product development.
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GxP Training |
It is important to make sure that everyone on your team understands the relevance of quality systems and knows how to apply them to projects. With extensive experience, including work in developing countries across Africa, we can provide training in all aspects of GxP, providing insight into EU, US FDA, WHO, or ICH guidance and regulations to meet the needs of your specific project. |
Clinical Services |
We conduct GCP audits of protocols, investigator sites, master files, pharmacovigilance, databases, and reports for a wide variety of clinical studies. With our expertise, you can be sure that we maintain quality at every stage. |
Laboratory Sevices |
When using laboratories, whether research (non-GLP), non-clinical (GLP), clinical (GCLP), or commercial product QC support (GMP) laboratories, you need to be sure that the data is credible and is in compliance with protocols, SOPs, and regulatory requirements. Constella QA can provide a comprehensive range of auditing services for all laboratory types. We can also offer expert advice and guidance in laboratory quality issues, assisting with establishing quality management systems, preparing laboratory policies and SOPs, and planning routine monitoring and QC procedures. |
